In-vivo Efficacy Study of Patient Preoperative Preps

NCT01968356 | Terminated Phase 3 Results

• 1 other identifier: EM-012759
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

Conditions

Skin Flora Bacterial Reduction Post-product Application

Keywords

surgical skin prep; CHG; IPA

Outcome Measures

Primary Outcomes (4)

• Responder Rate

  On the abdominal region a responder was a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours. On the inguinal region a responder was a subject with a 3-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours.

  baseline, 10 minute post-product application and 6 hour post-product application

• Skin Flora Baseline for Abdominal and Inguinal Regions

  Log10/cm2 baseline skin flora for abdominal and inguinal regions

  Baseline

• Skin Flora Recovery Post-treatment

  Log10/cm2 recovery of skin flora at 10 minutes and 6 hours following application of study treatments for abdominal and inguinal regions

  10 minutes and 6 hours post-treatment

• Reduction of Skin Flora Post-treatment

  Log10/cm2 reduction of skin flora, relative to Treatment Day baseline log10/cm2, at 10 minutes and 6 hours

  Baseline, 10 minutes and 6 hours

Secondary Outcomes (3)

• Safety as Assessed by Skin Irritation Scores

  Baseline

• Safety as Assessed by Skin Irritation Scores

  10 minutes post-treatment

• Safety as Assessed by Skin Irritation Scores

  6 hours post-treatment

Study Arms (4)

3M CHG/IPA Prep Colorless

EXPERIMENTAL

Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.

Drug: 3M CHG/IPA Prep Colorless

3M CHG/IPA Prep Tint

EXPERIMENTAL

Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.

Drug: 3M CHG/IPA Prep Tint

ChloraPrep Hi-Lite Orange

ACTIVE COMPARATOR

Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.

Drug: ChloraPrep

Normal Saline

PLACEBO COMPARATOR

Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.

Drug: Saline

Interventions

3M CHG/IPA Prep Colorless DRUG

Apply topically.

Also known as: Chlorhexidine glucontate and Isopropyl alcohol, CHG 2% / IPA 70%, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

3M CHG/IPA Prep Colorless

3M CHG/IPA Prep Tint DRUG

Apply topically.

Also known as: Chlorhexidine glucontate and Isopropyl alcohol, CHG 2%/IPA 70%, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

3M CHG/IPA Prep Tint

ChloraPrep DRUG

Apply topically.

Also known as: ChloraPrep One-Step, ChloraPrep Patient Preoperative Skin Preparation, 2% CHG/70% IPA, Chlorhexidine glucontate and Isopropyl alcohol, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

ChloraPrep Hi-Lite Orange

Saline DRUG

Apply topically.

Also known as: 0.9% NaCl, Normal Saline

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of any race
• Subjects in good general health
• Minimum skin flora baseline requirements on abdomen and groin

You may not qualify if:

• Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test areas
• Topical antimicrobial exposure within 14 days prior to screening and treatment days
• Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (1)

BioScience Laboratories, Inc.

Bozeman, Montana, 59718, United States

Location

MeSH Terms

Interventions

2-Propanol; Chromogranins; chlorhexidine gluconate; Ethanol; Sodium Chloride; Saline Solution

Intervention Hierarchy (Ancestors)

Propanols; Alcohols; Organic Chemicals; Nerve Tissue Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Joan E. Paulson
• Organization: 3M Health Care

jepaulson@mmm.com

651-736-6583

Study Officials

• Robert R McCormack, BS

  BioScience Laboratories, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: October 24, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 2, 2024
• Results First Posted: August 3, 2021

Record last verified: 2024-09

Locations

US (1)